2,2'-dimethyl-2,2'-azodipropiononitrile

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

Only 4 strains used. Less positive controls.

Principles of method if other than guideline:

Method according to Ames, B.N. et al.: Mutat. Res. 31, 347-364

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

2,2'-dimethyl-2,2'-azodipropiononitrile

EC Number:

201-132-3

EC Name:

2,2'-dimethyl-2,2'-azodipropiononitrile

Cas Number:

78-67-1

Molecular formula:

C8H12N4

IUPAC Name:

2,2'-dimethyl-2,2'-azodipropiononitrile

Details on test material:

2,2'-azobisisobutyronitrile; no data on purity of the compound

Specific details on test material used for the study:

common name: Porofor N, Pt. 23091979

Method

Target gene:

his

Species / strain

Species / strain / cell type:

other: Salmonella typhimurium TA98, TA100, TA1535, TA1537

Metabolic activation:

with and without

Metabolic activation system:

Aroclor 1254 induced rat liver microsomes

Test concentrations with justification for top dose:

20; 100; 500; 2,500; 12,500 ug/plate

Vehicle / solvent:

- DMSO for Porofor N, Trypaflavin and 2-aminoanthracene
- deion. water for Endoxan

Controls

Untreated negative controls:

other: vehicle control

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: Endoxan (Cyclophosphamid); Trypaflavin; 2-Aminoanthracene.

Results and discussion

Test results

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity, but tested up to precipitating concentrations

Remarks:

at 12,500 µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Any other information on results incl. tables

Since precipitation of the test substance was observed at 12,500 µg/plate, this dose level could not be evaluated.

Applicant's summary and conclusion

Conclusions:

Interpretation of results: negative

Based on the results of this study, the test substance Porofor N does not need to be classified according to EC/1272/2008 and 67/548/EEC.